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Medical Devices Certification

The Medical Devices Directive (MDD) applies to all general medical devices not covered by the Active Implantable Medical Devices Directive or the In Vitro Diagnostics Directive.

Our services include :

• Technical documentation/file or design dossier assessment/review
• Production quality assurance (based in ISO 13485)
• Full quality assurance (ISO13485)

The Medical Devices Instruction was adopted on 14 June 1993, as part of the process of removing barriers to free movement as well as of securing the safety aspects of medical devices within the EU/EFTA member states.

We facilitate certification process for various standards by leading agencies & authorities like Det Norske Veritas (DNV), Intertek, B.V.Q.I, T.U.V etc.

Why MSP can help you?

We facilitate certification process for various standards by leading agencies & authorities like Det Norske Veritas (DNV), Intertek, B.V.Q.I, T.U.V etc.